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NPPA reviews functioning of PMRU in Gujarat to assess compliance to DPCO
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Shardul Nautiyal, Mumbai
February 10 , 2021
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The National Pharmaceutical Pricing Authority (NPPA) officials visited Price Monitoring and Research Unit (PMRU) at the Gujarat Food and Drug Control Administration (FDCA) headquarters in Gandhinagar to review its progress and assess compliance to Drug Price Control Order (DPCO) -2013 and share experiences on the same for effective drug price ceiling regime in the country.
This comes close on the heels of Gujarat FDCA having referred 519 cases of ceiling price violations to NPPA from January 1 to December 31, 2020.
According to Gujarat FDCA Commissioner Dr HG Koshia, “NPPA Director and Deputy Director visited Gujarat FDCA office and reviewed the progress. We apprised them about the recruitment of manpower and how PMRU has been successfully functioning with the help of 7 personnel which includes a senior scientist having a Pharm D degree assisted with 3 more professionals having pharmacy degree along with 3 data operators. The pharmacy professionals have been trained in-house followed by week long rigorous field training to ensure that offenders don’t evade price violation.”
“The PMRU at Gujarat was formally launched on January 28, 2020 but we started the modalities of PMRU much earlier in September 2019 to ensure DPCO compliance and kick-started PMRU operations across all the 33 districts of the state from October 1, 2019 onwards to track price violations by the pharma companies,” Dr Koshia added.
PMRUs have also already been set up in 16 states including Goa, Kerala, Gujarat, Odisha, Rajasthan, Punjab, Haryana, Tripura, Uttar Pradesh, Nagaland, Mizoram, Jammu and Kashmir, Andhra Pradesh, Telangana and Karnataka.
Gujarat, Maharashtra, Karnataka, Andhra Pradesh are among the states which fall under the category of A states. NPPA has categorised the states based on three categories, i.e. based on maximum, minimum and least number of pharma companies in the state for better division of work.
NPPA had in 2016 proposed a plan to set up a ceiling price violation cell in each state to take action for any contravention to the provisions of Drug Price Control Order (DPCO-2013).
As per a notification, NPPA had proposed to set up PMRUs in states and Union territories (UTs) to support state drug controllers and through initiating a Central scheme of assistance at state level and UTs.
The NPPA has only an office in the national capital with no state level branches. The PMRUs were conceptualised to resolve this problem and the draft was announced way back in 2015.
“Each unit will function under the direct supervision of the state drug controller (SDC). PMRUs will be the key collaborating partners of NPPA, with information-gathering mechanism at the grassroots level. PMRUs will also ensure that the benefits of DPCO percolate down to the grassroots level. The central funding will be for an initial period of five years subject to a mid-term review,” the notification stated.
As per NPPA policy, PMRU shall be funded by NPPA for its recurring and non-recurring expenses. The PMRU shall help NPPA and SDC in ensuring availability and accessibility of medicines at affordable prices.
PMRU will also collect samples of medicines, collect and analyse data and make reports with respect to availability and over-pricing of medicines for taking action under the provisions of Drug Price Control Order (DPCO-2013).
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